Yoga for rheumatoid arthritis – A pilot randomised controlled trial

Not Applicable

Completed

• Conditions: Rheumatoid arthritis; Inflammatory and Immune System - Rheumatoid arthritis; Alternative and Complementary Medicine - Other alternative and complementary medicine

• Registration Number: ACTRN12612001019897
• Lead Sponsor: Dr Simon Stebbings

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-09-20
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Participants need to have a clinical diagnosis of rheumatoid arthritis, according to the American College of Rheumatology classification criteria; be aged 18 years or older; be able to understand written and spoken English; have baseline pain equal to or greater than 3 on a 10-point numeric rating scale; have baseline sleep disturbance equivalent to greater than 30 minutes to fall asleep or greater than 30 minutes awakened during the night; have had a stable medication regime for the previous 8 weeks; be able to self-mobilize in and out of a chair; agree to refrain from receiving or commencing other complementary and alternative medicine treatments or exercise programmes for the duration of the intervention; agree to notify researchers of any change in usual medications during the intervention, especially analgesics; and provide written informed consent.

Exclusion Criteria

Potential participants will be excluded if they already practice or have regularly practiced yoga in the previous 6 months; have recently had or expect to have surgery within 6 months of screening; have a medical condition, physical, or mental health impairment apart from RA that precludes their safe participation in exercise; are unable to commit to availability for the full course of the intervention; or have had or expect to have intra-articular steroid injections within 4 weeks of screening.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Outcome 1: Pain associated with rheumatoid arthritis in the past week, measured on a 10cm Visual Analogue Scale.[Timepoint: Weeks 0, 9 (1-week post-intervention), 12 (4 weeks post-intervention).];Primary Outcome 2: Sleep quality, measured with the Insomnia Severity Index[Timepoint: Weeks 0, 9 (1-week post-intervention), 12 (4 weeks post-intervention).]

Secondary Outcome Measures

Name	Time	Method
Secondary outcome 1: Functional disability will be assessed with the Health Assessment Questionnaire Disability Index (HAQ).[Timepoint: Weeks 0, 9 (1-week post-intervention), 12 (4 weeks post-intervention).];Secondary outcome 2: Disease activity will be assessed using the Clinical Disease Activity Index (CDAI)[Timepoint: Weeks 0, 9 (1-week post-intervention), 12 (4 weeks post-intervention).];Secondary outcome 3: Quality of life will be assessed with the generic Euroqol EQ-5D (EQ-5D).[Timepoint: Weeks 0, 9 (1-week post-intervention), 12 (4 weeks post-intervention).];Secondary outcome 4: Mental health will be measured with the Hospital Anxiety and Depression Scale (HADS).[Timepoint: Weeks 0, 9 (1-week post-intervention), 12 (4 weeks post-intervention).];Secondary outcome 5: Fatigue will be measured by the Bristol Rheumatoid Arthritis Fatigue Numerical Rating Scales (BRAF-NRS).[Timepoint: Weeks 0, 9 (1-week post-intervention), 12 (4 weeks post-intervention).]